Open Access Review

Article DOI: 10.7759/cureus.38311

Treatment Effectiveness of Clear Aligners in

Correcting Complicated and Severe Malocclusion
Review began 04/24/2023
Cases Compared to Fixed Orthodontic
Review ended 04/24/2023
Published 04/29/2023 Appliances: A Systematic Review
© Copyright 2023 Samer T. Jaber 1 , Mohammad Y. Hajeer 1 , Kinda Sultan 1
Jaber et al. This is an open access article
distributed under the terms of the Creative
Commons Attribution License CC-BY 4.0., 1. Department of Orthodontics, University of Damascus, Damascus, SYR
which permits unrestricted use, distribution,
and reproduction in any medium, provided
Corresponding author: Mohammad Y. Hajeer, myhajeer@gmail.com
the original author and source are credited.

Abstract
This systematic review aimed to critically assess the available evidence regarding the effectiveness and
efficiency of clear aligners in the comprehensive treatment of complex cases accompanied by premolars
extraction. An electronic literature search by two reviewers was independently done on 27 February 2023 in
the following databases without time and language limitations: Pubmed®, Scoups®, Google Scholar,
Cochrane Library database, Web of Science™, and Proquest Database Open. Randomized controlled trials
(RCTs) of any type, non-randomized clinical trials (CCT), cohort studies, and prospective, retrospective, and
cross-sectional studies were reviewed. The risk of bias in included studies was assessed using the Risk of Bias
(RoB 2.0) tool for randomized trials and the Risk of Bias in Non-randomized Studies (ROBINS-I) tool for non-
randomized studies. After carefully searching the literature, six trials were included in this systematic
review, three RCTs, two retrospective cohort studies, and one CCT. Two hundred eighty-three patients were
included (186 females, 97 males). Three studies found that there were no differences between the clear
aligners and fixed appliances when evaluations were done using the American Board of Orthodontists
Objective Grading System (ABO-OGS) or the Peer Assessment Rating (PAR) index. Two studies found that
there were some differences between predicted and achieved tooth movements when clear aligners were
used in premolars extraction cases. Based on the included studies, the duration of treatment was shorter
with fixed appliances than the clear aligners when applied to orthodontic extraction cases. Both clear
aligners and fixed appliances were found effective in the orthodontic treatment of premolar extraction-
based cases. Fixed appliances have the advantage of achieving better buccolingual inclination and occlusal
contacts in a shorter treatment duration. Treatment with clear aligners might be associated with differences
between predicted and achieved tooth movements. Therefore, the characteristics of these techniques should
be considered when making a treatment decision.

Categories: Dentistry, Oral Medicine

Keywords: crowding of teeth, clinical effectiveness, premolar extraction, systematic review, effectiveness, invisalign,
clear aligners, orthodontic

Introduction And Background

Malocclusion is often considered to have a negative impact on self-esteem and physical, social, and
psychological well-being [1]. Therefore, adults seek orthodontics treatment to enhance their smile,
occlusion, psychological well-being, and quality of life [2,3]. However, some of them resist proceeding with
the treatment due to the long treatment duration, discomfort, cost, and the unaesthetic appearance
accompanied by the conventional buccal fixed appliances [4]. With the advances in the orthodontic field,
invisible techniques have been introduced to patients offering them an aesthetic orthodontic treatment. The
lingual appliances provided an aesthetic advantage over the buccal ones, but their use was limited due to the
multiple difficulties associated with them [5-8]. In 1997, Invisalign® (Align Technology, San Jose, California)
was introduced, rendering Kesling's ideas a feasible orthodontic treatment option [9]. Clear aligners are a
series of removable plastic appliances that are used for moving teeth [10]. They have become more popular
due to the rapid development of digital three-dimensional (3D) technologies and dental materials [11,12].

With the advent of Invisalign®, the use of aligners was indicated for treating mild to moderate degrees of
crowding, mild to moderate spaces, correction of dental flaring and tipping, and for relapsed cases treated
previously using fixed appliances [13]. Over time, the range of the treated cases with clear aligners has
expanded from the treatment of simple orthodontic cases to more complex cases such as treatment of
anterior open bite [14], bimaxillary protrusion [15], excessive facial height, and severe dental crowding [16].
Treatment plans for these cases are often accompanied by premolars extraction, and this can present several
challenges during treatment, such as posterior anchorage control [17] and preserving the stability of the
closed spaces after treatment by ensuring root parallelism of the teeth adjacent to the extraction sites [18].

In the last decade, several reviews have emerged to evaluate the efficiency, effectiveness, and accuracy of
aligners in orthodontic treatments [19-21]. However, non of these reviews explicitly studied the scientific

How to cite this article

Jaber S T, Hajeer M Y, Sultan K (April 29, 2023) Treatment Effectiveness of Clear Aligners in Correcting Complicated and Severe Malocclusion
Cases Compared to Fixed Orthodontic Appliances: A Systematic Review. Cureus 15(4): e38311. DOI 10.7759/cureus.38311
 evidence that supports the effectiveness and efficiency of clear aligners in the orthodontic treatment of
complex extraction-based cases and their ability to achieve proper occlusion at the end of the treatment.
Therefore, this systematic review aimed to critically assess the available evidence regarding the
effectiveness and efficiency of clear aligners in the comprehensive treatment of complex cases accompanied
by premolars extraction. The focused review question was: "Are clear aligners effective in treating complex
extraction-based cases, and are they better than fixed appliances?".

Review
Materials & methods
Protocol and Registration

Before writing up the final protocol of this systematic review, a PubMed scoping search was performed to
verify the existence of similar systematic reviews and to explore potentially eligible articles. No systematic
review was found in the literature evaluating clear aligners' effectiveness in treating complex extraction-
based cases. During the first stage of the review, registration was done in the International Prospective
Register of Systematic Reviews (PROSPERO; CRD42022367851). This review was done according to the
Cochrane Handbook [22] and the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses
(PRISMA) statement [23].

Eligibility Criteria

Inclusion and exclusion criteria were established according to the Participants, Intervention, Comparisons,
Outcomes, and Study design (PICOS) framework, which was developed based on the focused review question
as follows; Participants: healthy human patients of any age, both genders, of all ethnic groups who have
complicated and severe malocclusion, and their treatment involved extraction of premolars (four or two
premolars). Intervention: orthodontic treatment using clear aligners. Comparisons: in the case of
comparative studies, the comparisons were made with fixed appliances. Outcomes: the primary outcome was
the comprehensive orthodontic treatment outcome evaluated using objective and reliable assessment
methods like the American Board of Orthodontics objective grading system (ABO-OGS), Peer Assessment
Rating (PAR) index, and evaluation of dental movements using analysis or superimposition of pre-and
posttreatment records. The secondary outcome was the treatment duration. Study design: Randomized
controlled trials (RCTs) of any type, non-randomized clinical trials (CCTs), and cohort studies. Prospective,
retrospective, and cross-sectional studies were reviewed. No limitations concerning language or publication
year were applied.

Search Strategy

An electronic literature search by two reviewers (Samer T. Jaber (STJ) and Mohammad Y. Hajeer (MYH)) was
independently done on 27 February 2023 in the following databases without time and language limitations:
Pubmed®, Scoups®, Google Scholar, Cochrane Library database, Web of Science™, and Proquest Database
Open (to identify dissertations and theses). Keywords and the details of the search strategy used are provided
in Table 1. The reference lists of selected papers and relevant reviews were screened for possible related
studies that the electronic web-based search may not have discovered.

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 Database Search strategy

#1 orthodontic* OR "clear aligner" OR "orthodontic appliances'' OR "orthodontic clear aligner" OR "Invisalign" OR "aligners''
CENTRAL
OR ''transparent aligners'' OR '' removable orthodontic appliances'' OR ''orthodontic treatment" OR "orthodontic Therapy" #2
(The
effect* OR effic* OR achieve OR predict OR outcome* OR advent* OR duration OR time. #3 extraction OR four premolars
Cochrane
extraction OR two premolars extraction. #4 malocclusion OR crowding OR bimaxillary protrusion*. #5 #3 OR #4 #6 #1 AND
Library)
#2 AND #5

#1 orthodontic* OR "clear aligner" OR "orthodontic appliances'' OR "orthodontic clear aligner" OR "Invisalign" OR "aligners''
OR ''transparent aligners'' OR '' removable orthodontic appliances'' OR ''orthodontic treatment" OR "orthodontic Therapy" #2
PubMed effect* OR effic* OR achieve OR predict OR outcome* OR advent* OR duration OR time. #3 extraction OR four premolars
extraction OR two premolars extraction. #4 malocclusion OR crowding OR bimaxillary protrusion*. #5 #3 OR #4 #6 #1 AND
#2 AND #5

#1 orthodontic* OR "clear aligner" OR "orthodontic appliances'' OR "orthodontic clear aligner" OR "Invisalign" OR "aligners''
OR ''transparent aligners'' OR '' removable orthodontic appliances'' OR ''orthodontic Treatment" OR "orthodontic Therapy" #2
EMBASE effect* OR effic* OR achieve OR predict OR outcome* OR advent* OR duration OR time. #3 extraction OR four premolars
extraction OR two premolars extraction. #4 malocclusion OR crowding OR bimaxillary protrusion*. #5 #3 OR #4 #6 #1 AND
#2 AND #5

#1 (clear aligner OR Invisalign) AND (effect OR effici) #2 orthodontic AND (clear aligner OR Invisalign) AND (severe crowding
Google
OR bimaxillary protrusion) #3 (clear aligner OR Invisalign) AND (extraction OR four premolars extraction OR two premolars
Scholar
extraction) #4 (clear aligner OR Invisalign) AND (predict OR achive OR actual)

#1 TITLE-ABS-KEY (orthodontic* OR "Invisalign" OR "clear aligners" OR "orthodontic appliances"). #2 TITLE-ABS-KEY

(effect* OR effic* OR predict* OR achieve* OR outcome) #3TITLEABS- KEY ("clear aligner" OR "Invisalign" OR "tranparent
Scopus aligners") AND (extracion* OR four premolars extraction* OR two premolars extraction*) #4 TITLE-ABS-KEY ("clear aligner"
OR "Invisalign") AND (severe crowding* OR bimaxillary protrusion* OR malocclusion*) #5 #1 AND #2 #6 #3 AND #5 #7 #4
AND #5

TS = (orthodontic applianc* OR orthodontic brack*) AND TS = (Invisalign OR clear align* OR invisible applianc* OR
Web of
orthodontic align* OR removable thermoplastic applianc*) AND TS = (orthodontic* OR malocclusion OR tooth crowding OR
Science
orthodontic treatment OR orthodontic patient*)

Proquest #1 (clear aligner OR Invisalign) AND (effect OR effici) #2 orthodontic AND (clear aligner OR Invisalign) AND (severe crowding
Database OR bimaxillary protrusion) #3 (clear aligner OR Invisalign) AND (extraction OR four premolars extraction OR two premolars
Open extraction) #4 (clear aligner OR Invisalign) AND (predict OR achive OR actual)

TABLE 1: The electronic search strategy

Study Selection and Data Extraction

Two reviewers (STJ & MYH) independently assessed the articles for suitability according to the inclusion
criteria; in case of disagreement, the third reviewer (Kinda Sultan (KS)) was asked to decide and resolve it. At
first, the titles and abstracts of the articles were screened during the search using the inclusion criteria by the
two reviewers. After that, the same two reviewers evaluated the full text of the screened articles that might
be included in the review. Any article that did not fulfill one or more of the inclusion criteria was discarded
from the review. Finally, the following data were extracted from each of the included articles using piloted
and predefined extraction sheets: general information (authors name, publication date, journal, country),
study design, participants' characteristics (size, age, eligibility criteria), intervention, teeth extracted,
treatment duration, assessment methods, and outcomes.

Risk of Bias of Individual Studies

The risk of bias in the included studies was assessed according to Cochrane guidelines with the Risk of Bias
(RoB 2.0) tool for randomized trials [24] and the Risk of Bias in Non-randomized Studies of Interventions
(ROBINS-I) tool for non-randomized studies [25]. Assessment of the risk of bias within individual trials was
likewise performed independently by the authors (STJ & MYH). The judgments of both authors were
compared. In case of disagreement and could not reach a consensus by discussion, a third reviewer (KS) was
asked to decide. For randomized studies, the following five domains were judged as having a high risk of
bias, low risk of bias, and some concerns: randomization process, deviations from intended interventions,
missing outcome data, measurement of the outcome, and selection of the reported result. After that, the
overall risk-of-bias judgment was reached according to the following criteria: low risk of bias if all the
domains were at low risk of bias, some concerns if there were some concerns in at least one domain without
any high risk of bias for any other domain, and high risk of bias if one or more fields were assessed as being

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 at high risk of bias or if there were some concerns for multiple domains in a way that substantially lowers
confidence in the result. For the evaluation of the non-randomized clinical trials with the ROBINS-I tool, the
evaluated criteria were divided into pre-intervention, intervention, and post-intervention categories. The
risk of bias was individually analyzed for each study and classified as low, moderate, serious, critical, and no
information.

Results
Literature Flow

A total of 1989 references were identified from an electronic databases search. One thousand two hundred
eighty-six citations were removed because of duplication, ineligibility by automation tools, and other
reasons. The titles and abstracts of 705 records were screened carefully for eligibility, and then all records
which were not fulfilling the inclusion criteria were eliminated. As a result, 16 potentially related records
were left for full-text assessment. Ten studies did not meet the inclusion criteria and were excluded from the
review. Subsequently, six trials were included in this systematic review. Figure 1 illustrates the Preferred
Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) flow diagram of the reviewing process.

FIGURE 1: The Preferred Reporting Items for Systematic Reviews and

Meta‐Analyses (PRISMA) flow diagram of the reviewing process.

Characteristics of the Retrieved Studies

Characteristics of the six studies included in this review are given in Table 2. Out of the six included studies
in this review, there were three RCTs [26-28], two retrospective cohort studies [29,30], and one CCT [16].
Three studies were from China [27,29,30]; three were from the USA [26], Italy [16], and Syria [28]. All of the
studies included males and females. The total participants involved in the included studies were 283
patients (186 females, 97 males); 177 of them were treated with clear aligners, while the rest of them (106
patients) were treated with traditional buccal fixed appliances. The average age of the patients ranged from

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 19.4 to 32.8 years. Only one study did not provide information about the age range [16]. All the included
studies used clear aligners provided by Invisalign® except for the Jaber et al. study, which used in-house
clear aligners. Three of these studies had control groups treated with traditional fixed appliances [16,27,28].
Whereas the other three studies were not comparative, i.e., there weren't control groups included in these
studies [26,29,30]. All of the studies involved extraction-based treatment; four of them included upper and
lower first premolars extraction [16,27,28,30] and one with only upper first premolars [29]. The last study
included cases with at least one premolar extraction [26]. Evaluation of clear aligners' effectiveness was done
using either the occlusal indices or tooth movement measurements on superimposed digital dental models
using a three-dimensional coordinate system generated for this purpose. Li et al. used the ABO-OGS to
evaluate the cases after appliance removal, whereas Gaffuri et al. used the same ABO grading system and
compared its components before and after treatment. Little's irregularity index (LII) and PAR index were
used in Jaber et al. study, whereas analysis and measurements of case records, including dental casts and
panoramic radiographs, were used in Baldwin et al. study. In contrast, Dai et al. used tooth movement
measurements after superimposing actual and virtual dental models as their evaluation method in their two
studies.

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 Population
Author Study Treatment Assessment
Country Intervention Outcomes assessed
(year) design Mean duration methods
Total Inclusion criteria
age

Age ≥ 18 years, ability to attend

Aligners:
Baldwin weekly appointments and to pay
24 pts 32.8 Invisalign® 16.9 Analysis of dental
et al. for services, requirement for Tooth tipping around
USA RCT (18 F, 6 (42.7 M, clear months, casts and panoramic
(2008) regular dental and periodontal extraction spaces
M) 29.4 F) aligners control: 23.2 radiographs
[26] maintenance program in case of
months
caries or periodontal disease

152 pts, Control:

Control:
control: Extraction patients. Class I Fixed Aligners:
32.2 ± Analysis of pre-and
Li et al. 76 (45 F, malocclusion; severity in appliances, 31.5
(8.3), posttreatment
(2015) China RCT 27 M), complexity with discrepancy aligners: months, ABO-OGS score system
aligners: records (study casts
[27] aligners: index score of 25, indicating high Invisalign® control: 22
35.2 ± and radiographs)
76 (45 F, complexity clear months
(7.3)
27 M) aligners

Differences between predicted Superimposition of

Patients who had been treated
22.3±(4.6) and achieved movement for actual pre-and
Dai et using clear aligners with
30 pts Invisalign® months for maxillary first molar and posttreatment models
al. Retrospective 19.4 ± extraction of two maxillary first
China (26 F, 4 clear the first central incisors Effects of age, with virtual pre-and
(2019) cohort study (6.3) premolars, and their first series
M) aligners series of initial crowding, and posttreatment using
[29] of aligners finished with no
aligners attachments on molar Rapidform 2007
midcourse correction
anchorage control software

Aligners: Pre- and

24 pts Control: 2.1 years posttreatment

(13 F, 11 MBT fixed plus records (digital

Gaffuri
M), Permanent dentition patients with appliances, maximum of ABO-OGS score system ABO models and
et al.
Italy CCT control: - severe crowding or bimaxillary aligners: G6 7 months standard cephalometric panoramic
(2020)
12, malocclusion Invisalign® for analysis radiographs) were
16]
aligners: clear refinements, analyzed with

12 aligners control: 2 AudaxCeph

years Advantage software

Superimposition of

Patients who had been treated the pretreatment,

21.0±(4.2) Comparing the predicted and
Dai et using clear aligners with predicted
17 pts ® months for achieved crown movements
Invisalign
al. Retrospective 25.4 ± extraction of four first premolars, posttreatment and
China (15 F, 2 clear the first of maxillary and mandibular
(2021) cohort study (5.0) and their first series of aligners actual posttreatment
M) aligners series of first molars, canines, and
[30] finished with no midcourse maxillary and
aligners central incisors
correction mandibular dental

models.

Control: Aligners:
Jaber Age 18-25 years Class I Fixed 23.27 ±
36 pts Analysis of pre-and
et al. 21.30 ± malocclusion with severe appliances (5.82), LII, PAR index, treatment
Syria RCT (24 F, 12 posttreatment study
(2022) (2.29) crowding, which requires the Aligners: In- control: duration
M) casts
[28] extraction of the first premolars house clear 26.20 ±

aligners (5.27)

TABLE 2: Characteristics of the included studies in this systematic review

RCT - randomized controlled trial, F - female, M - male, pts - patients, ABO-OGS - American Board of Orthodontics - Objective Grading System, LII -
Little's irregularity index, PAR - Peer Assessment Rating

Risk of Bias in the Included Studies

The summary of the risk of bias in the included studies is shown in Figures 2-5. For the RCTs, one was at
high risk of bias [26], whereas the other had some concerns [27,28]. Blinding was the most problematic field
in both studies. For the other three non-RCT included studies, two were at serious risk of bias [29,30], and
one was at low risk [16]. Those with serious risks had severe issues with the selection of participants in the

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 study and also had a moderate bias in the classification of interventions. More details about the risk of bias
assessment and the supporting reasons for each assessment are given in Tables 3 and 4.

FIGURE 2: Risk of bias summary: the review authors' judgments about

each item of the risk of bias for the randomized controlled trial studies
Red circle - high risk of bias; yellow circle - some concerns; green circle - low risk of bias

Domains: D1: Bias arising from the randomization process; D2: Bias due to deviations from the intended
intervention; D3: Bias due to missing outcome data; D4: Bias in measurement of the outcome; D5: Bias in the
selection of the reported result.

FIGURE 3: Risk of bias summary: the review authors' judgments about

each item's risk of bias for the non-randomized controlled trials
Red circle - serious risk of bias; yellow circle - moderate risk of bias; green circle - low risk of bias.

Domains: D1: Bias due to confounding; D2: Bias due to selection of participants; D3: Bias in the classification of
interventions; D4: Bias due to deviations from intended interventions; D5: Bias due to missing data; D6: Bias in
measurement of outcomes; D7: Bias in selection of the reported result.

FIGURE 4: Risk of bias graph for the randomized controlled trials: the
review authors' judgments about each item's risk of bias, presented as
percentages across all the studies included

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 FIGURE 5: Risk of bias graph for the non-randomized controlled trials:
the review authors' judgments about each item's risk of bias, presented
as percentages across all the studies included

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 Domains

Bias due to deviations from

intended interventions
Bias due to
Study Bias arising from Bias in the
missing Bias in the selection of the Overall
the randomization Effect of measurement of the
Effect of outcome reported results bias
process assignment outcome
adhering to data
to
interventions
interventions

Some Some
Some concerns:
concerns: concerns:
Blinding cannot
Blinding Missing High risk: The method of Low risk: The assessed High risk:
be performed,
Some concerns: cannot be outcome data measuring the outcome numerical result has not The study
and ''no
Randomization performed. balanced in was not appropriate. The probably been selected based is judged
information'' on
schedule is based on There is ''no numbers outcome assessors were on the results from multiple to raise
Baldwin et whether the
a list of random information'' across the principal investigator eligible outcome measurements high risk
al. important non-
numbers performed on whether intervention (who was not blinded for within the outcome domain and because
(2008)[26] protocol
by a calibrated any groups, with the assignment of each analysis of the data. The eligible one of the
interventions
investigator unaware deviations similar intervention) and the reported results for the outcome domains
were balanced
of the treatment plan. arose reasons for other two dentists who corresponded to the intended got this
across
because of missing data were blinded. outcome measurements. result
intervention
the trial across
groups.
context. groups.

Some
Some concerns:
Low risk: concerns: Some
Blinding cannot
Randomization using Blinding Low risk: The assessed concerns:
be performed,
a computer- cannot be numerical result has not The study
and ''no
generated sequence performed. Low risk: The method of probably been selected based is judged
information'' on
performed by There is ''no measuring the outcome on the results from multiple to raise
whether the Low risk: No
Li et al. Statistical Analysis information'' was appropriate. The eligible outcome measurements some
important non- dropouts were
(2015)[27] System. on whether outcome assessor was within the outcome domain and concerns
protocol reported
Randomization was any blind for the assignment analysis of the data. The eligible because
interventions
concealed using deviations of each intervention. reported results for the outcome one of the
were balanced
opaque envelopes by arose corresponded to the intended domains
across
two clinicians not because of outcome measurements. got this
intervention
involved in the study the trial result
groups.
context.

Some Somxxxe
Low risk: concerns: concerns: Some
Randomization using Blinding Blinding cannot Low risk: The assessed concerns:
a computer- cannot be be performed, numerical result has not The study
generated sequence performed. and ''no Low risk: The method of probably been selected based is judged
performed by There is ''no information'' on measuring the outcome on the results from multiple to raise
Jaber et Low risk: No
Statistical Analysis information'' whether the was appropriate. The eligible outcome measurements some
al. dropouts were
System. on whether important non- outcome assessor was within the outcome domain and concerns
(2022)[28] reported
Randomization was any protocol blind for the assignment analysis of the data. The eligible because
concealed using deviations interventions of each intervention. reported results for the outcome one of the
opaque envelopes by arose were balanced corresponded to the intended domains
two clinicians not because of across outcome measurements. got this
involved in the study the trial intervention result
context. groups.

TABLE 3: Risk of bias of the included randomized controlled trials

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 Domains

Pre-intervention Intervention Post-intervention

Bias due to
Study Bias Bias in the Overall
deviations
Bias due to Bias in selection of Bias in classification due to measurement Bias in selection bias
from
confounding participants into the study on interventions missing of the of reported results
intended
data outcome
interventions

Low: The Serious

Low: The protocol
outcome risk: The
was approved by
measure was study is
Serious: Selection of Moderate: The Low: No the institutional
unlikely to be judged to
Dai et participants into the study interventional group devition from Low: No review board. The
Low: No influenced by raise
al. based on characteristics clearly defined, but the the intended dropouts pre-defined
confounding knowledge of serious risk
(2019) observed after the start of the definition recorded after intervention were outcomes
is expected. the because
[29] intervention. The interention the start of the was reported. mentioned in the
intervention one of the
started before the follow-up. intervention. observed. methods section
received by domains
seemed to have
study got this
been reported.
participants result

Low: The
Low: The interventional outcome Low: The protocol
Low: All participants who group clearly defined at measure was was approved by Low risk:
Low: No
would have been eligible for the start of the unlikely to be the University. The The study
Gaffuri devition from Low: No
Low: No the target trial were included intervention. influenced by pre-defined is judged to
et al. the intended dropouts
confounding in the study. Furthermore, for classification of knowledge of outcomes be at low
(2020) intervention were
is expected. each participant, the start of intervention status the mentioned in the risk of bias
[16] was reported.
follow-up and the start of wasn't affected by intervention methods section for all
observed.
intervention coincided. knowledge of the received by seemed to have domains.
outcome. study been reported.
participants

Low: The Serious

Low: The protocol
outcome risk: The
was approved by
measure was study is
Serious: Selection of Moderate: The Low: No the institutional
unlikely to be judged to
Dai et participants into the study interventional group devition from Low: No review board. The
Low: No influenced by raise
al. based on characteristics clearly defined, but the the intended dropouts pre-defined
confounding knowledge of serious risk
(2021) observed after the start of the definition recorded after intervention were outcomes
is expected. the because
[30] intervention. The interention the start of the was reported. mentioned in the
intervention one of the
started before the follow-up. intervention. observed. methods section
received by domains
seemed to have
study got this
been reported.
participants result

TABLE 4: Risk of bias of the included non-randomized controlled trials

Effects of Interventions

The main findings of the included studies are given in Table 5. The high clinical heterogeneity among the
retrieved studies (variability in the studies' designs, in the studies' outcomes, and the patient's ages) did not
allow for conducting a quantitative synthesis of the data in a meta-analysis.

Author
Results Conclusion
(Year)

In premolar extraction patients

treated with Invisalign,
significant dental tipping
During treatment, the average radiographic changes in interdental angle were 21.5° (p<0.0001; occurs (it can be corrected
Baldwin n = 10) in the mandible and 16.3° (p<0.0001; n = 19) in the maxilla. On the models, the average with fixed appliances). There
et al. changes were 20.8° (p<0.0001; n = 12) in the mandible and 15.9° (p<0.0001; n = 20) in the is a trend for greater tipping of

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 (2008) maxilla No subject completed the initial series of aligners, and only one ultimately completed mandibular teeth into the
[26] treatment with aligners. extraction space and around
the second premolar
extraction sites during
treatment with aligners.

According to the OGS scores,

both techniques were
Improved total mean scores of the OGS categories after treatment for both groups in terms of successful in the treatment
Li et al.
alignment, marginal ridges, occlusal relations, overjet,inter-proximal contacts, and root of class I extraction
(2015)
angulation Invisalign® scores were significantly lower than fixed appliance scores for cases. Fixed appliances were
[27]
buccolingual inclination and occlusal contacts. superior in buccolingual
inclination and occlusal
contacts.

Retraction of the central

incisors and anchorage
control of the first molars were
First molars: Tipped mesially with a difference of 5.86°±3.51°. Translated mesially more than
not achieved as predicted.
Dai et predicted by 2.26±1.56 mm as indicated by mesiobuccal cusp and 2.31±1.67 mm as indicated
Auxiliaries and overcorrection
al. by distobuccal cusp. The mesiobuccal cusp intruded more than predicted by 0.61±0.89 mm; the
should be considered to help
(2019) distobuccal cusp was stable. Central incisors: Tipped more lingually by 5.16°±5.92°. The
achieve the predicted
[29] retraction was less than predicted by 2.21±1.51 mm and extruded more than predicted by
movement. Achieving the
0.50±1.17 mm.
predicted plan is affected by
age, attachments, and initial
crowding.

Both techniques are effective

Gaffuri Improved total mean scores of the OGS categories after treatment for both groups, and there
for four premolars extraction
et al. were no significant differences between the two groups. There were no significant differences
cases if accurate diagnosis
(2020) between the initial and final cephalometric measurements for both intra and inter-group
and appropriate protocols are
[16] differences.
used.

Maxillary first molars: tipped mesially and lingually, whereas they were predicted to tip distally
and labially, with significant differences between the predicted and actual changes. For the
rotation, there were no significant differences between the changes. Mandibular first molars: Central incisors and canines
there were no significant differences between predicted and actual changes for tipping, but the achieved greater distal
differences were significant for the rotation with more mesiolingual rotation than predicted. tipping, and lingual inclination,
Dai et Maxillary canines: No significant changes for the inclination and rotation, whereas the and insufficient retraction and
al. angulation changes were significant with more distal tipping than predicted. Mandibular intrusion than predicted. First
(2021) canines: tipped significantly more than predicted distally and lingually. Rotation was more than molars showed greater mesial
[30] predicted mesiobuccally, with no significant differences. Maxillary central incisors: for the tipping, buccal inclination,
angulation and rotation, there were no significant changes between the predicted and achieved rotation, intrusion, mesial
changes. Inclination changes were significant towards lingual. Mandibular central incisors: there displacement, and less
were significant differences in the inclination and angulation with the teeth tipping toward the constriction than predicted.
distal and lingual. There were no significant changes in the rotation between predicted and
actual changes.

No significant differences
between the CA and FA
groups for any of the
components of the PAR index
after the end of treatment. In-
No significant differences in the LII for the upper and lower jaws between the two studied
house clear aligners can be
Jaber groups No significant differences in all studied PAR domains between the two groups. In the CA
effective in the treatment of
et al. group, the mean score reduction was 28.39 (±8.51) points, whereas it was 26.39 (±5.76) points
complex orthodontic cases,
(2022) in the FA group. In both groups, all the patients were improved. Great improvement was
including premolars extraction
[28] achieved in 88.9% of the patients in the CA group and 91.7% in the FA group. The treatment
if a suitable teeth movement
duration was close in both groups with no significant difference between them.
protocol is used. No
difference in the treatment
duration were observed with
in-house clear aligners and
fixed appliances.

TABLE 5: Overview of the results and conclusions of the included studies

ABO-OGS - American Board of Orthodontics - Objective Grading System, LII - Little's irregularity index, PAR - Peer Assessment Rating, CA - clear

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 aligners, FA - fixed appliances

Treatment Effectiveness

When occlusal indices were used to evaluate treatment effectiveness, Li et al. found that the total mean
scores of the OGS categories improved after treatment in the clear aligners and fixed appliances groups
regarding alignment, marginal ridges, occlusal relations, overjet, inter-proximal contacts, and root
angulation. In contrast, fixed appliances scores were significantly better than Invisalign® scores for
buccolingual inclination and occlusal contacts [27]. Gaffuri et al. found that the clear aligners and fixed
appliances techniques improved total mean scores of the OGS categories after treatment, with no significant
differences between them [16]. When comparing in-house aligners with conventional fixed appliances, Jaber
et al. found no significant differences in the LII for the upper and lower jaws between the two groups. Also,
the two groups had no significant differences in all studied PAR domains. The CA group's mean score
reduction was 28.39±8.51 points, whereas it was 26.39±5.76 in the FA group. In both groups, 100% of the
patients were improved.

In contrast, a great improvement was achieved in 88.9% of the patients in the CA group and 91.7% in the FA
group [28]. Baldwin et al. found that the average radiographic changes in interdental angle were 21.5° in the
mandible and 16.3° in the maxilla. On the models, the average changes were 20.8° in the mandible and 15.9°
in the maxilla. No subject in this study completed the initial series of aligners; only one patient ultimately
completed treatment with aligners [26]. When evaluating effectiveness by measuring the tooth movements
on superimposed predicted and achieved dental models, Dai et al. found in their first study that the
orthodontic treatment with upper first premolars extraction led to a mesial tipping of the first molars with a
mean difference of 5.86°±3.51° from the predicted models, mesial translation was also observed for the first
molars in a greater extent than the predicted values by a mean of 2.26±1.56 mm and 2.31±1.67 mm when
measured at the mesiobuccal cusp and the distobuccal cusp, respectively. For the central incisors, tipping
was observed in the actual models more lingually by 5.16°±5.92° than predicted. Also, the retraction of the
central incisors was less than predicted by 2.21±1.51 mm, whereas extrusion was more than predicted by
0.50±1.17 mm [29]. In their second study that included orthodontic treatments with upper and lower first
premolars extraction, Dai et al. found that the central incisors and canines achieved greater distal tipping
and lingual inclination and insufficient retraction and intrusion than predicted. In contrast, the first molars
showed greater mesial tipping, buccal inclination, rotation, intrusion, mesial displacement, and less
constriction than predicted [30].

Treatment Efficiency

Efficiency was evaluated by calculating the treatment duration. Baldwin et al. found that for premolar
extraction cases, clear aligner treatment required more time than treatment with fixed appliances alone [26].
Jaber et al. found that the treatment duration with clear aligners was shorter than that with fixed appliances,
with no significant differences between them [28]. In contrast, Li et al. and Gaffuri et al. found that the
treatment duration with the fixed appliances was shorter than that with the clear aligners [16,27]. Dai et al.
studies found that the first set of clear aligners takes an average of 22.3±4.6 and 21.0±4.2 months in
orthodontic treatment with two premolars and four premolars extraction, respectively [29,30].

Discussion
To the best of our knowledge, the present systematic review is the first in the literature to evaluate clear
aligners' clinical effectiveness in treating complex orthodontic cases with teeth extraction. This review
summarizes the evidence from six trials (involving 283 patients) out of initially identified 1989 studies from
the literature, taking into consideration orthodontic treatment using clear aligners in teeth extraction cases.
Three trials were judged as having a serious risk of bias [26,29,30], two had some concerns [27,28], and one
had a low risk of bias [16]. Participant blinding was the most problematic field. These judges might affect the
level of certainty of the achieved results.

Considerable variation in the investigated clinical outcomes was noted among the included studies. When
evaluating the achieved occlusal traits after orthodontic treatment, similar levels of effectiveness in
achieving acceptable and comparable occlusion were found in both techniques. Upper and lower alignment
components were the most improved after orthodontic treatments in both groups. [16,27,28]. Li et al. found
that the buccolingual inclination and occlusal contacts were not good as those achieved by the fixed
appliances [27]. It is well known that achieving good interocclusal contacts is a key factor in preserving
posttreatment stability regardless of the class of malocclusion being treated [31]. Jaber et al. found that the
anterioposterior relationships between the upper and lower teeth were lower in the clear aligners groups
than the fixed appliances, with no significant differences between them [28].

The differences between the two techniques might be attributed to the precise teeth movements resulting
from the accurate positioning of the brackets at the beginning of the treatment and the possibility of
repositioning them during the treatment as well as the MBT prescription of the brackets. Using pre-adjusted

2023 Jaber et al. Cureus 15(4): e38311. DOI 10.7759/cureus.38311 12 of 15

 fixed appliances also allows orthodontists to make precise wire adjustments within 0.5mm to intrude or
extrude teeth as necessary and to make fine adjustments with uprighting or rotation springs, interarch
elastics, and other auxiliaries [16].

In contrast, extrusion movements with aligners are considered difficult, and teeth occlusal surfaces coverage
with the aligners during treatment; both these factors prevented the occlusion's final settling. That is why
clear aligners could not produce adequate occlusal contacts compared to the achieved results with fixed
appliances. The same problem is found when minor vertical dental movements are required at the end of the
orthodontic treatment (i.e., settling) but cannot be achieved due to using vacuum-formed retainers in the
retention phase [32]. Moreover, it's hard to guarantee the desired treatment results with clear aligners
because success relies on patients' motivation and dependability to complete the treatment, as clear aligners
are removable [21].

When aligners' effectiveness was evaluated by tooth movement measurements on superimposed digital
dental models, two aspects were evaluated: the anchorage control and teeth retraction by comparing the
predicted and achieved movements of the first molars, central incisors, and canines. The first molar
anchorage control, represented by mesial tipping and mesial displacement, was not fully achieved as
predicted. The amount of maxillary anchorage loss was one-third of the extraction space. In contrast, the
mandibular first molar showed better anchorage control than the maxillary first molar, with a smaller
achieved amount and a minor difference between achieved and predicted amounts [29,30]. This finding is in
accordance with that of fixed orthodontic treatment because the maxillary molars move mesially more easily
than the mandibular molars, and the maxillary anterior segment includes larger teeth than the mandibular
anterior segment. Retraction of canines and central incisors was less than predicted in the maxilla but the
same as predicted in the mandible. Maxillary and mandibular canines achieved notably more distal tipping
than predicted, and both maxillary and mandibular central incisors achieved notably more lingual
inclination than predicted [29,30]. These findings suggest that tipping movement rather than bodily
movement is more likely to occur with canines and central incisors during extraction space closure with
clear aligners.

When efficiency was evaluated, different results were found according to the four studies that compared the
treatment duration between fixed appliances and clear aligners; three of them found that treatment with
clear aligners takes more time than that with fixed appliances [16,26,27], while one study found no
differences between the two techniques regarding the treatment duration [28]. The acceleration of
orthodontic tooth movement has recently become a critical topic in the orthodontic literature [33-37]. Many
physical, biomechanical, and surgical techniques have been suggested to reduce orthodontic treatment time
[38-40]. Thus, based on the existing literature about clear aligners, the duration of treatment was shorter
with fixed appliances when applied to orthodontic extraction cases. This aspect should be explicitly
discussed with patients before choosing the clear aligner treatment modality.

Limitations

There was a lack of large- and high-quality studies investigating the effectiveness of clear aligners in
treating complex orthodontic cases with premolars extraction. The number of randomized controlled trials
included in this review was small, and cohort studies were included in this systematic review. This might
result in bias due to its retrospective design and the bias in selecting participants for these studies. There
was incomplete reporting of the potential confounding factors in all studies included in this review, like oral
hygiene, compliance, type and number of bonded attachments, number of aligners, rate of refinement
aligners needed, or the amount of interproximal reduction (IPR) applied.

Conclusions
Both clear aligners and fixed appliances are effective in the orthodontic treatment of premolar extraction-
based cases. Fixed appliances have the advantage of achieving better buccolingual inclination and occlusal
contacts in a shorter treatment duration. Treatment with clear aligners might be associated with differences
between predicted and achieved tooth movements. Therefore, the characteristics of these techniques should
be considered when making a treatment decision. More well-conducted high-quality studies are needed,
with more consideration of the sample size and trial design to study the effectiveness of clear aligners on
various types of complex malocclusion cases.

Additional Information
Disclosures
Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the
following: Payment/services info: All authors have declared that no financial support was received from
any organization for the submitted work. Financial relationships: All authors have declared that they have
no financial relationships at present or within the previous three years with any organizations that might
have an interest in the submitted work. Other relationships: All authors have declared that there are no
other relationships or activities that could appear to have influenced the submitted work.

2023 Jaber et al. Cureus 15(4): e38311. DOI 10.7759/cureus.38311 13 of 15

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